Engineer Validation – 1st Shift

Job Description

Our client is a Fortune 500 Pharmaceutical Company with Global reach. They are currently looking for a strong Validation Engineer to join there tenured Validation team.

Key responsibilities for this role include:

• Provide direction, reviews and provides Quality approval for design qualification documents, validation protocols, summary reports, discrepancy reports and CPV reports.
• Provides the Quality Assurance review and approval of Engineering, Calibration, Facility Maintenance, Production Support (Maintenance), Technical Services and IT procedures and forms.
• Authors protocols and reports as required/assigned.
• Perform validation planning and tracking.
• Assist in the development and maintenance of the procedures defining the validation program at MTI.
• Participates in the evaluation of changes to validated systems to ensure the validate state is maintained. Provides direction, reviews and approves proposed changes and facilitates decision making regarding the extent of any re-validation requirements.
• Assist in the compilation of periodic reports required by the validation program.

The minimum qualifications for this role are:

• Bachelor of Science degree (or equivalent) and 7 + years in a pharmaceutical cGMP environment is required. A combination of experience and/or education will be taken into consideration.
• Must possess a working knowledge of Pharmaceutical validation and cGMP concepts.